Infarct Reduction Technologies, Inc.
A therapeutic development company
Monday, April 8, 2013
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Infarct Reduction Technologies Inc. is set out to capitalize on a recent discovery that a series of intermittent occlusions of blood flow to an upper arm trigger the human body to activate a host of protective reactions which greatly reduce ischemic damage elsewhere in the body. This therapy is known as remote ischemic conditioning. Over the last few years, this non-invasive therapy was applied using a manually-inflated blood pressure cuff in over 70 clinical studies involving 10,000+ patients - confirming a strong reduction in ischemic damage of 40-60% and reassuring lack of side effects. While the most intriguing applications include heart attack (about 1 million cases per year in US alone) and stroke (800,000 cases in US), other applications of the therapy extend from cardiac and liver surgery to traumatic brain injury, and even to severe blood loss and trauma - remote conditioning is beneficial in all cases when blood flow is temporarily stopped regardless of why it happens.
Yet, despite its efficacy, the therapy is difficult to deliver in a chaotic environment of treating a heart attack patient and rapid transfers from home to ambulance, followed by the emergency room and then cardiac cathlab. The procedure takes 40 min and there is a need for someone to stay with the patient this entire time. To assure proper delivery of the therapy, IRT is developing an automatic device called LifeCuff designed not only to inflate and deflate the cuff accurately and consistently, but also monitor patient's blood pressure at the same time. In addition, LifeCuff is capable of providing remote conditioning at the lowest cuff pressure to minimize patient's discomfort. The product is designed to be simple in use: once positioned on the upper arm of the patient, it is activated with a single START button - after that the entire operation is conducted automatically without further human involvement. In that sense, LifeCuff is designed to allow simple application of the therapy as an adjunct to other treatments. The objective of the product is to deliver the benefits of the therapy without delaying other treatments but in parallel with them.
3 Major Issues
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Business Strategy:
As a small company, IRT does not anticipate to build its own sales force and do its own distribution. How far in the development cycle does it have to go in order to attract strategic partners? Plan at this point is to create a clinical prototype, conduct a small scale heart attack study and obtain FDA clearance. Does it have to demonstrate repeated history of early sales?
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Regulatory:
Although remote conditioning is a non-invasive procedure shown to be at least safe in many published studies, there is no predicate device allowing IRT to claim substantial equivalence under a 510(k) route of FDA clearance. While at some future point, it expects to conduct a heart attack study in support of a PMA application to reduce infarct size, is there an opportunity to cite the existing literature for evidence of safety and apply for a 510(k) using a de-novo route?
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Other Opportunities:
With limited resources, IRT is concentrating all efforts on a heart attack application and a disposable product configuration. At the same time, it has filed patent applications for other product configurations and treatment methods for other conditions. Other than securing IP, is there a way for IRT to exploit other opportunities such as perhaps finding new sources of funding from licensing the underlying technology to other fields?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Boris Leschinsky, CEO of IRT, will deliver the Company's "Elevator" Pitch to the Group
8:20 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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